K912190 is an FDA 510(k) clearance for the STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 29, 1991, 104 days after receiving the submission on May 17, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4210.
| 510(k) Number | K912190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1991 |
| Decision Date | August 29, 1991 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDZ — Mixer, Cement, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4210 |